Therapeutic Targeting of Sex Differences in Pediatric Brain Tumor Glycolysis

• Status: Recruiting
• Trial end date: 2032-05-31
• Target enrollment: 0
• Participant gender: All

Summary

The investigators will develop the concept of a sex-specific therapeutic intervention for gliomas that is based upon dietary carbohydrate restriction. The investigators will integrate metabolomics tools and FDG-PET imaging to validate the ketogenic diet on a sex-specific basis.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Carmustine

Criteria

Inclusion Criteria:

• Diagnosis of a recurrent primary brain tumor with no curative therapy available.

• Measurable disease using pediatric Response Assessment in Neuro-Oncology Criteria (RANO) criteria.

• Life expectancy > 12 weeks

• Prior treatment with radiation alone, chemotherapy alone or combined radiation and chemotherapy is allowed.

• Patient is < 21 years of age

• Normal bone marrow and organ function as defined below:

• Leukocytes ≥ 3,000/mcL

• Absolute neutrophil count ≥ 1,500/mcl

• Platelets ≥ 100,000/mcl

• Total bilirubin ≤ 1.5 x IULN

• AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN

• Creatinine ≤ IULN OR creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal

• Normal room air oxygenation must be documented. If room air oxygen saturation is less than 97%, a diffusion capacity of carbon monoxide (DLCO) of greater than 80%, must be demonstrated.

• Karnofsky or Lansky performance score of ≥ 60

• Patients of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a female patient become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.

• Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

• Patient does not have any of the following conditions as they are contraindicated for ketogenic diet:

• Primary and secondary carnitine deficiency

• Carnitine palmitoyltransferase I or II deficiency

• Carnitine translocase deficiency

• Mitochondrial β-oxidation defects

• Pyruvate carboxylase deficiency

• Glycogen storage diseases

• Ketolysis defects

• Ketogenesis defects

• Porphyria

• Prolonged QT syndrome

• Liver insufficiency

• Renal insufficiency

• Pancreatic insufficiency

• Pulmonary insufficiency

• Hyper insulinism

• Pregnant and/or breastfeeding. Female patients of childbearing potential must have a negative pregnancy test within 14 days of study entry.